all report title image
  • Published On : Aug 2022
  • Code : CMI4481
  • Industry : Pharmaceutical
  • Pages : 211
  • Formats :

These are specialized types of drug manufacturing organizations that serve a critical role in the patient care, as stated by the United States Pharmacopoeia (USP), compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies, or rare diseases. The 503B compounding pharmacies are required to be registered with the U.S. FDA and maintain full compliance with the current good manufacturing practices (cGMP).

The cGMP guidelines compounding pharmacies needs to follow are 503B compounding pharmacies are must validate every process according to CGMP.

503B facilities must produce multiple batches and submit them for testing and stability before a new product can be brought to market.

503B products and testing methods must be validated according to US pharmacopeia (USP). Similarly, all suppliers and vendors providing raw materials must be evaluated. Moreover, onsite inspection must be performed by quality personnel.

Market Dynamics

The increasing launches of 503B compounding pharmacies in the U.S and increasing adoption of inorganic growth strategies such as mergers, acquisitions, partnerships, and collaborations by key players operating in the market are the major factors that are expected to drive growth of the U.S. 503B compounding pharmacies market over the forecast period.

For instance, in January 2022, Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, announced the launch of Hikma 503B, a new outsourced sterile compounding business focused on providing high quality, ready to administer injectable medications that are customized to the specific need of patients in the U.S.

Key features of the study:

  • This report provides an in-depth analysis of the U.S. 503B compounding pharmacies market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the U.S. 503B compounding pharmacies market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Central Admixture Pharmacy Services, Inc., Nephron Pharmaceuticals Corporation, QuVa Pharma, Olympia Pharmacy, ASP Cares, Fagron Compounding Pharmacies, Athenex, Inc., Avella Specialty Pharmacy, Atlas Pharmaceuticals, Empower Pharmacy, Carie Boyd’S Prescription Shop, Edge Pharma, Imprimis NJOF, LLC, IntegraDose Compounding services, LLC, Wells Pharma of Houston, LLC, US Compounding Inc., and SCA Pharma
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The U.S 503B Compounding pharmacies market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the U.S. 503B compounding pharmacies market.

Detailed Segmentation:

  • U.S. 503B Compounding pharmacies Market, By Molecule:
    • Acetaminophen
    • Phenylephrine
    • Midazolam
    • Esmolol
    • Vancomycin
    • Epinephrine
    • Adenocaine
    • Fentanyl/ Bupivacaine
    • Morphine
    • Amiodarone
    • Heparin
    • Ketamine
    • Dextrose
    • Hydromorphone
    • Bupivacaine
    • Lidocaine
    • BKK (Bupivacaine, ketorolac, Ketamine)
    • RCK (Ropivacaine, Clonidine, Ketorolac)
    • RKK (Ropivacaine, Ketorolac, Ketamine)
    • Other Molecules
  • U.S 503B Compounding Pharmacies Market, By Packaging:
    • Vials
    • Prefilled Syringes
    • Ampoules
    • Syringes
    • Others
  • Company Profiles
    • Central Admixture Pharmacy Services, Inc.*
      • Company Overview
      • Material Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Nephron Pharmaceuticals Corporation
    • QuVa Pharma
    • Olympia Pharmacy
    • ASP Cares
    • Fagron Compounding Pharmacies
    • Athenex, Inc.
    • Avella Specialty Pharmacy
    • Atlas Pharmaceuticals
    • Empower Pharmacy
    • Carie Boyd’S Prescription Shop
    • Edge Pharma, Imprimis NJOF
    • IntegraDose Compounding services
    • Wells Pharma of Houston, LLC
    • US Compounding Inc.
    • SCA Pharma

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Molecule
      • Market Snippet, By Packaging
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Pipeline Analysis
    • PEST Analysis
    • Regulatory Scenario
    • Market Trends
    • Key Highlights
    • Mergers & Acquisitions
  4. U.S 503B Compounding Pharmacies Market – Impact of Coronavirus (Covid-19) Pandemic
    • Economic Impact
    • Impact on Clinical Trials
    • Government Initiatives
  5. U.S 503B Compounding Pharmacies Market, By Molecule, 2017 – 2030, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2017 – 2030
      • Segment Trends
    • Acetaminophen
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Phenylephrine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Midazolam
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Esmolol
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Vancomycin
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Epinephrine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Adenocaine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Fentanyl/ Bupivacaine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Morphine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Amiodarone
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Heparin
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Ketamine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Dextrose
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Hydromorphone
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Bupivacaine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Lidocaine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • BKK (Bupivacaine, ketorolac, Ketamine)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • RCK (Ropivacaine, Clonidine, Ketorolac)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • RKK (Ropivacaine, Ketorolac, Ketamine)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Other Molecules
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
  6. U.S. 503B Compounding Pharmacies Market, By Packaging, 2017 – 2030, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2017 – 2030
      • Segment Trends
    • Vials
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Prefilled Syringes
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Ampoules
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Syringes
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Mn)
  7. Competitive Landscape
    • Heat Map Analysis
    • Market Share Analysis
      • Central Admixture Pharmacy Services, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Nephron Pharmaceuticals Corporation
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • QuVa Pharma
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Olympia Pharmacy
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • ASP Cares
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Fagron Compounding Pharmacies
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Athenex, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Avella Specialty Pharmacy
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Atlas Pharmaceuticals
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Empower Pharmacy
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Carie Boyd’S Prescription Shop
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Edge Pharma
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Imprimis NJOF, LLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • IntegraDose Compounding services, LLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Wells Pharma of Houston, LLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • US Compounding Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • SCA Pharma
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  8. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 6 market data tables and 32 figures on "U.S. 503B Compounding Pharmacies Market” - forecast to 2030.

EXISTING CLIENTELE

Joining thousands of companies around the world committed to making the Excellent Business Solutions.

View All Our Clients
trusted clients logo